CN1121213C - 缓释组合物的制备方法 - Google Patents

缓释组合物的制备方法 Download PDF

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Publication number
CN1121213C
CN1121213C CN94118503A CN94118503A CN1121213C CN 1121213 C CN1121213 C CN 1121213C CN 94118503 A CN94118503 A CN 94118503A CN 94118503 A CN94118503 A CN 94118503A CN 1121213 C CN1121213 C CN 1121213C
Authority
CN
China
Prior art keywords
diluent
mixture
granule
carrier
tablet
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CN94118503A
Other languages
English (en)
Chinese (zh)
Other versions
CN1116521A (zh
Inventor
R·B·米勒
S·T·莱斯利
S·T·A·马尔考斯卡
D·A·普雷特
T·J·诺特
J·希菲尔德
D·查里斯
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Euro Celtique SA
Original Assignee
Euro Celtique SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from GB9324045A external-priority patent/GB2284760B/en
Priority claimed from GB9403922A external-priority patent/GB2288117A/en
Priority claimed from GB9404544A external-priority patent/GB9404544D0/en
Priority claimed from GB9404928A external-priority patent/GB2287880A/en
Priority claimed from EP94303128A external-priority patent/EP0624366B1/en
Priority claimed from EP94304144A external-priority patent/EP0636370B2/en
Priority claimed from GB9411842A external-priority patent/GB9411842D0/en
Application filed by Euro Celtique SA filed Critical Euro Celtique SA
Publication of CN1116521A publication Critical patent/CN1116521A/zh
Publication of CN1121213C publication Critical patent/CN1121213C/zh
Application granted granted Critical
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Pain & Pain Management (AREA)
  • Biomedical Technology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
CN94118503A 1993-11-23 1994-11-23 缓释组合物的制备方法 Expired - Lifetime CN1121213C (zh)

Applications Claiming Priority (14)

Application Number Priority Date Filing Date Title
GB9324045.5 1993-11-23
GB9324045A GB2284760B (en) 1993-11-23 1993-11-23 A method of preparing pharmaceutical compositions by melt pelletisation
GB9403922.9 1994-03-01
GB9403922A GB2288117A (en) 1994-03-01 1994-03-01 Sustained release morphine
GB9404544A GB9404544D0 (en) 1994-03-09 1994-03-09 Controlled release formulation
GB9404544.0 1994-03-09
GB9404928.5 1994-03-14
GB9404928A GB2287880A (en) 1994-03-14 1994-03-14 Production of sustained release compositions
EP94303128A EP0624366B1 (en) 1993-05-10 1994-04-29 Controlled release formulation containing tramadol
EP94303128.6 1994-04-29
EP94304144.2 1994-06-09
EP94304144A EP0636370B2 (en) 1993-07-01 1994-06-09 Sustained release compositions containing morphine
GB9411842.9 1994-06-14
GB9411842A GB9411842D0 (en) 1994-06-14 1994-06-14 Pharmaceutical preparation

Publications (2)

Publication Number Publication Date
CN1116521A CN1116521A (zh) 1996-02-14
CN1121213C true CN1121213C (zh) 2003-09-17

Family

ID=27562143

Family Applications (1)

Application Number Title Priority Date Filing Date
CN94118503A Expired - Lifetime CN1121213C (zh) 1993-11-23 1994-11-23 缓释组合物的制备方法

Country Status (17)

Country Link
EP (1) EP0654263B1 (cs)
JP (2) JP3411114B2 (cs)
CN (1) CN1121213C (cs)
AT (1) ATE212224T1 (cs)
AU (1) AU682223C (cs)
BG (1) BG62429B1 (cs)
CZ (1) CZ289650B6 (cs)
DE (1) DE69429710T2 (cs)
DK (1) DK0654263T3 (cs)
ES (1) ES2168290T3 (cs)
FI (1) FI113335B (cs)
HU (1) HU217205B (cs)
IL (1) IL111709A (cs)
NO (1) NO314124B1 (cs)
NZ (1) NZ264953A (cs)
PT (1) PT654263E (cs)
SK (1) SK280496B6 (cs)

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RS49982B (sr) 1997-09-17 2008-09-29 Euro-Celtique S.A., Sinergistička analgetička kombinacija analgetičkog opijata i inhibitora ciklooksigenaze-2
NZ505193A (en) 1997-12-22 2003-03-28 Euro Celtique S Opioid agonist/antagonist combinations
US6375957B1 (en) 1997-12-22 2002-04-23 Euro-Celtique, S.A. Opioid agonist/opioid antagonist/acetaminophen combinations
DE19901687B4 (de) * 1999-01-18 2006-06-01 Grünenthal GmbH Opioide Analgetika mit kontrollierter Wirkstofffreisetzung
DE19901683B4 (de) * 1999-01-18 2005-07-21 Grünenthal GmbH Analgetikum mit kontrollierter Wirkstofffreisetzung
DE19923551A1 (de) * 1999-05-21 2000-11-30 Lohmann Therapie Syst Lts Pharmazeutisches Präparat mit dem Wirkstoff Diamorphin und seine Verwendung in einem Verfahren zur Behandlung der Opiatsucht
SK285128B6 (sk) 1999-12-28 2006-07-07 Zentiva, A. S. Liečivý prípravok s riadeným uvoľňovaním obsahujúci tramadol hydrochlorid a spôsob jeho prípravy
US20030065002A1 (en) 2001-05-11 2003-04-03 Endo Pharmaceuticals, Inc. Abuse-resistant controlled-release opioid dosage form
JP4755810B2 (ja) 2002-04-05 2011-08-24 ユーロ−セルティーク エス．エイ． オキシコドン及びナロキソンを含有する医薬製剤
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US8487002B2 (en) 2002-10-25 2013-07-16 Paladin Labs Inc. Controlled-release compositions
DE10300325A1 (de) 2003-01-09 2004-07-22 Hexal Ag Granulat mit öliger Substanz, Herstellungsverfahren und Tablette
DE102004032051A1 (de) 2004-07-01 2006-01-19 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten, festen Darreichungsform
DE10336400A1 (de) 2003-08-06 2005-03-24 Grünenthal GmbH Gegen Missbrauch gesicherte Darreichungsform
DE102005005446A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Bruchfeste Darreichungsformen mit retardierter Freisetzung
US20070048228A1 (en) 2003-08-06 2007-03-01 Elisabeth Arkenau-Maric Abuse-proofed dosage form
DE10361596A1 (de) 2003-12-24 2005-09-29 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
US8075872B2 (en) 2003-08-06 2011-12-13 Gruenenthal Gmbh Abuse-proofed dosage form
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DE102004032049A1 (de) * 2004-07-01 2006-01-19 Grünenthal GmbH Gegen Missbrauch gesicherte, orale Darreichungsform
AR050615A1 (es) * 2004-08-27 2006-11-08 Novartis Ag Composiciones farmaceuticas para la administracion oral
GB2418854B (en) 2004-08-31 2009-12-23 Euro Celtique Sa Multiparticulates
DE102005005449A1 (de) 2005-02-04 2006-08-10 Grünenthal GmbH Verfahren zur Herstellung einer gegen Missbrauch gesicherten Darreichungsform
EP1702558A1 (en) 2005-02-28 2006-09-20 Euro-Celtique S.A. Method and device for the assessment of bowel function
CA2616204C (en) 2005-09-09 2015-12-01 Labopharm Inc. Sustained drug release composition
PT1931346E (pt) 2005-09-09 2012-08-14 Angelini Labopharm Llc Composição de trazodona para administração uma vez por dia
ES2516693T3 (es) 2006-03-16 2014-10-31 Euro-Celtique S.A. Esferoides farmacéuticos
SA07280459B1 (ar) 2006-08-25 2011-07-20 بيورديو فارما إل. بي. أشكال جرعة صيدلانية للتناول عن طريق الفم مقاومة للعبث تشتمل على مسكن شبه أفيوني
DE102007011485A1 (de) 2007-03-07 2008-09-11 Grünenthal GmbH Darreichungsform mit erschwertem Missbrauch
WO2009092601A1 (en) 2008-01-25 2009-07-30 Grünenthal GmbH Pharmaceutical dosage form
HRP20161307T1 (hr) 2008-05-09 2016-12-02 Grünenthal GmbH Postupak za pripravu praškaste formulacije međuproizvoda i konačni kruti oblik doziranja uz korištenje koraka zgrušavanja raspršivanjem
KR20140141727A (ko) 2009-03-10 2014-12-10 유로-셀티큐 에스.에이. 옥시코돈 및 날록손을 포함하는 즉시 방출 제약 조성물
DE102009019268A1 (de) * 2009-04-28 2010-11-11 Lts Lohmann Therapie-Systeme Ag Arzneimittel mit poröser Matrix
ES2534908T3 (es) 2009-07-22 2015-04-30 Grünenthal GmbH Forma de dosificación de liberación controlada extruida por fusión en caliente
ES2428938T3 (es) 2009-07-22 2013-11-12 Grünenthal GmbH Forma de dosificación resistente a la manipulación y estabilizada frente a la oxidación
AU2011297901B2 (en) 2010-09-02 2014-07-31 Grunenthal Gmbh Tamper resistant dosage form comprising inorganic salt
AU2011297892B2 (en) 2010-09-02 2014-05-29 Grunenthal Gmbh Tamper resistant dosage form comprising an anionic polymer
AU2012292418B2 (en) 2011-07-29 2017-02-16 Grunenthal Gmbh Tamper-resistant tablet providing immediate drug release
RS56528B1 (sr) 2011-07-29 2018-02-28 Gruenenthal Gmbh Tableta za trenutno oslobađanje leka rezistentna na zloupotrebu
EP2819656A1 (en) 2012-02-28 2015-01-07 Grünenthal GmbH Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
EP2838512B1 (en) 2012-04-18 2018-08-22 Grünenthal GmbH Tamper resistant and dose-dumping resistant pharmaceutical dosage form
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
AU2014273227B2 (en) 2013-05-29 2019-08-15 Grunenthal Gmbh Tamper-resistant dosage form containing one or more particles
BR112015029616A2 (pt) 2013-05-29 2017-07-25 Gruenenthal Gmbh forma de dosagem resistente à adulteração com perfil de liberação bimodal
CA2917136C (en) 2013-07-12 2022-05-31 Grunenthal Gmbh Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
US10071089B2 (en) 2013-07-23 2018-09-11 Euro-Celtique S.A. Combination of oxycodone and naloxone for use in treating pain in patients suffering from pain and a disease resulting in intestinal dysbiosis and/or increasing the risk for intestinal bacterial translocation
BR112016010482B1 (pt) 2013-11-26 2022-11-16 Grünenthal GmbH Preparação de uma composição farmacêutica em pó por meio de criomoagem
JP2017518980A (ja) 2014-05-12 2017-07-13 グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング タペンタドールを含む、改変防止即時放出カプセル製剤
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CN115248141A (zh) * 2021-04-28 2022-10-28 北京泰德制药股份有限公司 一种制备缓释药物组合物检测样品的方法

Citations (3)

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Publication number Priority date Publication date Assignee Title
US4132753A (en) * 1965-02-12 1979-01-02 American Cyanamid Company Process for preparing oral sustained release granules
WO1993018753A1 (en) * 1992-03-20 1993-09-30 Kabi Pharmacia Ab Process for the preparation of sustained release pellets
CN1102323A (zh) * 1993-07-01 1995-05-10 欧洲凯尔特公司 缓释组合物及制备药用组合物的方法

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SE9003296L (sv) * 1990-10-16 1992-04-17 Kabi Pharmacia Ab Foerfarande foer att formulera laekemedel

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4132753A (en) * 1965-02-12 1979-01-02 American Cyanamid Company Process for preparing oral sustained release granules
WO1993018753A1 (en) * 1992-03-20 1993-09-30 Kabi Pharmacia Ab Process for the preparation of sustained release pellets
CN1102323A (zh) * 1993-07-01 1995-05-10 欧洲凯尔特公司 缓释组合物及制备药用组合物的方法

Also Published As

Publication number Publication date
CZ289650B6 (cs) 2002-03-13
EP0654263B1 (en) 2002-01-23
FI113335B (fi) 2004-04-15
HU217205B (hu) 1999-12-28
AU7901594A (en) 1995-06-01
FI945476L (fi) 1995-05-24
BG62429B1 (bg) 1999-11-30
IL111709A0 (en) 1995-01-24
NO314124B1 (no) 2003-02-03
JPH07196475A (ja) 1995-08-01
HU9403353D0 (en) 1995-02-28
AU682223B2 (en) 1997-09-25
NO944473L (no) 1995-05-24
SK140694A3 (en) 1995-07-11
IL111709A (en) 2002-12-01
BG99198A (en) 1995-08-28
EP0654263A1 (en) 1995-05-24
FI945476A0 (fi) 1994-11-22
ATE212224T1 (de) 2002-02-15
ES2168290T3 (es) 2002-06-16
DE69429710T2 (de) 2002-08-08
NZ264953A (en) 1996-11-26
PT654263E (pt) 2002-06-28
AU682223C (en) 2005-03-24
HUT74910A (en) 1997-03-28
CN1116521A (zh) 1996-02-14
CZ286694A3 (en) 1995-06-14
JP2003113075A (ja) 2003-04-18
JP3411114B2 (ja) 2003-05-26
DE69429710D1 (de) 2002-03-14
SK280496B6 (sk) 2000-03-13
DK0654263T3 (da) 2002-04-29
NO944473D0 (no) 1994-11-22

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